Noninvasive devices, methods and systems for shrinking of tissues

ABSTRACT

The invention provides improved devices, methods, and systems for shrinking of collagenated tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient&#39;s own support tissues. This energy heats fascia and other collagenated support tissues, causing them to contract. The energy can be applied intermittently, often between a pair of large plate electrodes having cooled flat electrode surfaces, the electrodes optionally being supported by a clamp structure. Such cooled plate electrodes are capable of directing electrical energy through an intermediate tissue and into fascia while the cooled electrode surface prevents injury to the intermediate tissue, particularly where the electrode surfaces are cooled before, during, and after an intermittent-heating cycle. Ideally, the plate electrode comprises an electrode array including discrete electrode surface segments so that the current flux can be varied to selectively target the fascia. Alternatively, chilled “liquid electrodes” may direct current through a selected portion of the bladder (or other body cavity) while also cooling the bladder wall, an insulating gas can prevent heating of an alternative bladder portion and the adjacent tissues, and/or ultrasound transducers direct energy through an intermediate tissue and into fascia with little or no injury to the intermediate tissue. Cooled electrodes may be used to chill an intermediate engaged tissue so as to cause the maximum temperature difference between the target tissue and the intermediate tissue prior to initiating RF heating. This allows the dimensions of tissue reaching the treatment temperature to be controlled and/or minimized, the dimensions of protected intermediate tissue to be maximized, and the like.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of and claims the benefit of priorityfrom U.S. patent application Ser. No. 10/338,193, which is a divisionalof U.S. patent application Ser. No. 09/765,923 filed Jan. 19, 2001, nowU.S. Pat. No. 6,558,381, which is a divisional of U.S. patentapplication Ser. No. 09/133,496 filed Aug. 12, 1998, now U.S. Pat. No.6,216,704, which is a continuation-in-part of U.S. patent applicationSer. Nos. 08/910,775, now U.S. Pat. No. 6,480,746, Ser. No. 08/910,369,now U.S. Pat. No. 6,035,238, and Ser. No. 08/910,371, now U.S. Pat. No.6,081,749, all filed Aug. 13, 1997, and U.S. Provisional PatentApplication Nos. 60/071,418; 60/071,419; 60/071,422; and 60/071,323, allfiled Jan. 14, 1998, the full disclosures of which are incorporatedherein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to medical devices, methods, andsystems. More specifically, the present invention provides techniquesfor selectively heating and shrinking tissues, particularly for thenoninvasive treatment of urinary incontinence and hernias, for cosmeticsurgery, and the like.

Urinary incontinence arises in both women and men with varying degreesof severity, and from different causes. In men, the condition occursmost often as a result of prostatectomies which result in mechanicaldamage to the sphincter. In women, the condition typically arises afterpregnancy where musculoskeletal damage has occurred as a result ofinelastic stretching of the structures which support the genitourinarytract. Specifically, pregnancy can result in inelastic stretching of thepelvic floor, the external sphincter, and most often, to the tissuestructures which support the bladder and bladder neck region. In each ofthese cases, urinary leakage typically occurs when a patient'sintra-abdominal pressure increases as a result of stress, e.g. coughing,sneezing, laughing, exercise, or the like.

Treatment of urinary incontinence can take a variety of forms. Mostsimply, the patient can wear absorptive devices or clothing, which isoften sufficient for minor leakage events. Alternatively oradditionally, patients may undertake exercises intended to strengthenthe muscles in the pelvic region, or may attempt behavior modificationintended to reduce the incidence of urinary leakage.

In cases where such non-interventional approaches are inadequate orunacceptable, the patient may undergo surgery to correct the problem. Avariety of procedures have been developed to correct urinaryincontinence in women. Several of these procedures are specificallyintended to support the bladder neck region. For example, sutures,straps, or other artificial structures are often looped around thebladder neck and affixed to the pelvis, the endopelvic fascia, theligaments which support the bladder, or the like. Other proceduresinvolve surgical injections of bulking agents, inflatable balloons, orother elements to mechanically support the bladder neck.

Each of these procedures has associated shortcomings. Surgicaloperations which involve suturing of the tissue structures supportingthe urethra or bladder neck region require great skill and care toachieve the proper level of artificial support. In other words, it isnecessary to occlude or support the tissues sufficiently to inhibiturinary leakage, but not so much that intentional voiding is madedifficult or impossible. Balloons and other bulking agents which havebeen inserted can migrate or be absorbed by the body. The presence ofsuch inserts can also be a source of urinary tract infections.Therefore, it would be desirable to provide an improved therapy forurinary incontinence.

A variety of other problems can arise when the support tissues of thebody have excessive length. Excessive length of the pelvic supporttissues (particularly the ligaments and fascia of the pelvic area) canlead to a variety of ailments including, for example, cystocele, inwhich a portion of the bladder protrudes into the vagina. Excessivelength of the tissues supporting the breast may cause the breasts tosag. Many hernias are the result of a strained, torn, and/or distendedcontaining tissue, which allows some other tissue or organ to protrudebeyond its contained position. Cosmetic surgeries are also oftenperformed to decrease the length of support tissues. For example,abdominoplasty (often called a “tummy tuck”) is often performed todecrease the circumference of the abdominal wall. The distortion ofthese support tissues may be due to strain, advanced age, congenitalpredisposition, or the like.

Unfortunately, many support tissues are difficult to access, and theirtough, fibrous nature can complicate their repair. As a result, thetherapies now used to improve or enhance the support provided by theligaments and fascia of the body often involve quite invasive surgicalprocedures.

For these reasons, it would be desirable to provide improved devices,methods, and systems for treating fascia, tendons, and the other supporttissues of the body. It would be particularly desirable to provideimproved noninvasive or minimally invasive therapies for these supporttissues, especially for the treatment of urinary incontinence in men andwomen. It would further be desirable to provide treatment methods whichmade use of the existing support structures of the body, rather thandepending on the specific length of an artificial support structure.

2. Description of the Background Art

U.S. Pat. No. 5,423,811 describes a method for RF ablation using acooled electrode. U.S. Pat. Nos. 5,458,596 and 5,569,242 describemethods and an apparatus for controlled contraction of soft tissue. AnRF apparatus for controlled depth ablation of soft tissue is describedin U.S. Pat. No. 5,514,130.

U.S. Pat. No. 4,679,561 describes an implantable apparatus for localizedheating of tissue, while U.S. Pat. No. 4,765,331 describes anelectrosurgical device with a treatment arc of less than 360 degrees. Animpedance and temperature generator control is described in U.S. Pat.No. 5,496,312. Bipolar surgical devices are described in U.S. Pat. Nos.5,282,799, 5,201,732, and 728,883.

SUMMARY OF THE INVENTION

The present invention provides devices, methods, and systems forshrinking of collagenated tissues, particularly for treating urinaryincontinence in a noninvasive manner. In contrast to prior arttechniques, the present invention does not rely on implantation ofballoons or other materials, nor does it rely on suturing, cutting, orother direct surgical modifications to the natural support tissues ofthe body. Instead, the present invention directs energy to a patient'sown support tissues. This energy heats fascia and other collagenatedsupport tissues, causing them to contract without substantial necrosisof adjacent tissues. The energy will preferably be applied through alarge, cooled electrode having a substantially flat electrode surface.Such a cooled plate electrode is capable of directing electrical energythrough an intermediate tissue and into fascia, while the cooledelectrode surface prevents injury to the intermediate tissue. Ideally,the plate electrode comprises an electrode array which includes severaldiscrete electrode surface segments so that the current flux can bevaried to selectively target and evenly heat the fascia. In someembodiments, the tissue is heated between a pair of parallel cooledelectrode surfaces, the parallel surfaces optionally being planar,cylindrical, spherical, or the like. Alternatively, the tissue may betreated with a bipolar probe, particularly after pre-cooling theintermediate tissue to selectively vary tissue impedance and therebydirect the heating current through the target tissue.

In a first aspect, the present invention provides a probe fortherapeutically heating a target tissue of a patient body through anintermediate tissue. The probe comprises an electrode with an electrodesurface which is engageable against the intermediate tissue. Theelectrode surface is substantially flat, and a cooling system is coupledto the electrode. The cooling system allows the electrode surface tocool the engaged intermediate tissue while an electrical current fluxfrom the electrode surface therapeutically heats the target tissue.

The electrode surface will generally be sufficiently flat to direct thecurrent flux through the cooled intermediate tissue and into the targettissue while the cooling system maintains the intermediate tissue at orbelow a maximum safe tissue temperature. To direct the current flux,heating may be provided between a pair of electrode surfaces, theelectrode surfaces typically being separated by a distance from about ⅓to about 5.0 times the least width of the electrodes, preferably beingseparated by a distance from about ½ to about 2.0 times the leastelectrode width. In many embodiments, a temperature sensor will monitorthe temperature of the target tissue or the intermediate tissue. Acontrol system will often selectively energize the electrode and/orcooling system in response to the monitored temperature.

In another aspect, the present invention provides a probe for applyingenergy to fascia from within the vagina of a patient body. The fascia isseparated from the vagina by a vaginal wall. The probe comprises a probebody having a proximal end and a distal end, the probe having a lengthand a cross-section selected to permit introduction into the vagina. Anenergy transmitting element is mounted to the probe body. Thetransmitting element is capable of transmitting sufficient heatingenergy through the vaginal wall to heat and contract the fascia. Acooling system is disposed adjacent to the transmitting element. Thecooling system is capable of maintaining the vaginal wall adjacent theprobe below a maximum safe temperature when the fascia is heated by thetransmitting element.

The present invention also provides a method for shrinking a targetcollagenated tissue within a patient body through an intermediatetissue. The method comprises directing energy from a probe, through theintermediate tissue, and into the target tissue. The energy heats thetarget tissue so that the target tissue contracts. The intermediatetissue is cooled with the probe to avoid injuring the intermediatetissue when the target tissue is heated by the probe.

In yet another aspect, the present invention provides a method fordirecting energy into a target tissue of a patient body through anintermediate tissue. The method comprises electrically coupling a firstelectrode to the patient body. A second electrode is electricallycoupled to the intermediate tissue, the second electrode being mountedon a probe. The intermediate tissue is cooled by the probe, and anelectrical potential is applied between the first and second electrodes.An electrode surface of the second electrode is sufficiently large andflat to provide a current flux that extends through the cooledintermediate tissue so that the current flux heats the target tissue.

In yet another aspect, the present invention provides a method fortherapeutically heating a target zone of a tissue within a patient body.The method comprises engaging a tissue adjacent to the target zone witha probe. The adjacent tissue is pre-cooled with the probe, and thetarget zone is heated by directing energy from the probe, through thepre-cooled adjacent tissue, and into the target zone.

In another aspect, the present invention provides a kit for shrinking atarget collagenated tissue within a patient body through an intermediatetissue. The kit comprises a probe having an energy transmitting elementadapted to direct an energy flux through the intermediate tissue andinto the target tissue. A cooling system is adjacent to the transmittingelement to cool the intermediate tissue. The kit also includesinstructions for operating the probe. The instructions comprise thesteps of directing energy from the energy transmitting element of theprobe, through the intermediate tissue, and into the target tissue so asto heat and shrink the target tissue. The intermediate tissue is cooledwith the cooling system of the probe to avoid injuring the intermediatetissue.

In a further aspect, the present invention further provides a method forteaching. The method comprises demonstrating cooling of a surface with aprobe. Directing of energy from the probe is also demonstrated, theenergy being directed through the surface and into the underlyingstructure to effect shrinkage of the structure.

In yet another aspect, the present invention provides a system fortherapeutically heating a target zone within a tissue. The systemcomprises a first electrode having a first electrode surface which isengageable against the tissue. A second electrode has a second electrodesurface which can be aligned substantially parallel to the firstelectrode surface, with the tissue positioned therebetween. Anelectrical current flux between these parallel electrodes cansubstantially evenly heat the target zone. A cooling system is coupledto at least one of the electrodes for cooling the electrode surface.Generally, radiofrequency current is used to avoid tissue stimulation.

In another aspect, the present invention provides a method fortherapeutically heating a target zone of a patient body. The target zoneis disposed within a tissue between first and second tissue surfaces.The method comprises engaging a first electrode surface against thefirst tissue surface. A second electrode surface is alignedsubstantially parallel with the first electrode surface and against thesecond tissue surface. An electrical potential is applied between thefirst and second electrodes so as to produce an electrical current fluxwhich heats the target zone. At least one of the first and second tissuesurfaces is cooled by the engaged electrode.

The present invention also provides a probe for heating a target tissueof a patient body through an intermediate tissue. The probe comprises aprobe body supporting an electrode array. The electrode array includes aplurality of electrode surface segments. The electrode surface segmentsare simultaneously engageable against the intermediate tissue, and acooling system is coupled to the probe for cooling the electrode surfacesegments. A control system is also coupled to the electrode surfacesegments. The control system is adapted to selectively energize theelectrode surface segments so as to heat the target tissue to atreatment temperature while the cooling system maintains theintermediate tissue (which is disposed between the electrode array andthe target zone) at or below a maximum safe tissue temperature.

In another aspect, the present invention provides a method fortherapeutically heating a target zone of a tissue within a patient body.The method comprises engaging a probe against the tissue. The probe hasa plurality of electrode surface segments, and the tissue is cooledadjacent the probe by the electrode surface segments. An electricalcurrent flux is directed from the electrode surface segments, throughthe cooled tissue, and into the target zone by selectively energizingthe electrode surface segments so that the current flux substantiallyevenly heats the target zone.

In some embodiments of the present invention, tissue contraction energywill preferably be in the form of a radiofrequency (RF) electricalcurrent applied through an electrolytic solution. Often times, theelectrolytic solution will be introduced into the patient's bladderthrough a transurethral probe, and will provide electrical couplingbetween an electrode of the probe and the bladder wall. To enhancecontrol over the therapeutic heating and shrinking of tissues appliedinternally through an electrolytic solution, a controlled volume of boththe electrolytic solution and an electrically and thermally insulatinggas can be introduced into the patient's bladder (or some other hollowbody organ). By orienting the patient so that the electricallyconductive solution is positioned within the bladder adjacent the pelvicsupport tissues, the conductive solution can transmit electrical currentover a relatively large and fairly well controlled interface between theconductive solution and the bladder wall, while the gas preventstransmission of the RF energy to the delicate abdominal tissues abovethe bladder. The electrically conductive solution may also providedirect cooling of the bladder wall before, during, and/or after thetherapeutically heating RF energy is transmitted. Such cooling may beenhanced by circulating chilled conductive solution through the bladder,optimizing the electrical properties of the solution to minimize heatgenerated within the solution, and the like. In the exemplaryembodiment, the RF energy is transmitted between the electrolyte/bladderwall interface and a cooled, substantially flat electrode of a vaginalprobe so as to shrink the endopelvic fascia therebetween and therebyinhibit incontinence.

In this aspect of the present invention, a method for heating a targettissue within a patient body heats tissue separated from a body cavityby an intermediate tissue. The method comprises introducing a conductivefluid into the cavity. An electrical current is passed from theconductive fluid, through the intermediate tissue, and into the targettissue to effect heating of the target tissue. The intermediate tissueis cooled by the conductive fluid. The conductive fluid will generallycomprise an electrolytic solution such as saline, and the saline willpreferably be chilled. Advantageously, by directing RF current betweensuch a chilled electrolytic solution and a large cooled plate electrode,an intermediate collagenated tissue therebetween can be selectivelyraised above about 60° C., thereby inducing shrinkage. The tissue whichis engaged directly by the cooled electrode and chilled electrolyticsolution (on either side of the collagenated tissue) is preferablymaintained below a maximum safe temperature of about 45° C.

In another aspect, the invention provides a method for shrinking atarget tissue within a patient body. The target tissue is separated froma body cavity by an intermediate tissue. The method comprisesintroducing a conductive fluid and an insulating fluid into the cavity.These fluids are positioned within the cavity by orienting the patient.The conductive and insulating fluids will have differing densities, andthe patient will be oriented so that the conductive fluid is disposedadjacent the target tissue, while the insulating fluid is disposed awayfrom the target tissue. The target tissue can then be heated by passingan electrical current from the conductive fluid, through theintermediate tissue, and into the target tissue. The intermediate tissuecan also be cooled by the conductive fluid. The conductive fluid willoften comprise an electrolytic liquid such as saline, while theinsulating fluid will typically comprise a gas such as air, carbondioxide, or the like. By carefully controlling the volumes of thesefluids within the body cavity, and by properly orienting the patient,gravity and the differing electrical properties of these containedfluids can be used to selectively transfer RF current from an electrodeto a relatively large, controlled surface area of the body cavitywithout requiring the introduction of a large or mechanically complexelectrode structure.

In another aspect, the present invention provides a method for treatingurinary incontinence. The method comprises introducing a fluid into thebladder, and transmitting electrical current from the fluid, through thebladder wall, and into a pelvic support tissue so that the current heatsand shrinks the pelvic support tissue and inhibits urinary incontinence.The bladder wall is cooled with the conductive fluid.

In another aspect, the present invention provides a system for shrinkinga pelvic support tissue of a patient body. The pelvic support tissue isseparated from a urinary bladder by a bladder wall. The system comprisesa first probe having a proximal end and a distal end adapted fortransurethral insertion into the bladder. A first electrode is disposednear the distal end, as is a fluid in-flow port. A sealing member isproximal of the in-flow port for sealing a conductive fluid within thebladder such that the first electrode is electrically coupled to thebladder wall by the conductive fluid. A second electrode is adapted fortransmitting current to a tissue surface of the patient body withoutheating the tissue surface. A power source is coupled to the first andsecond electrodes to heat and shrink the pelvic support tissue. In manyembodiments, the second electrode will comprise a cooled plate electrodeof a vaginal probe, so that the endopelvic fascia can be selectivelyheated between the vagina and the conductive fluid within the bladder.

In another aspect, the present invention provides a system for shrinkinga pelvic support tissue of a patient body. The pelvic support tissue isseparated from a urinary bladder by a bladder wall. The system comprisesa first probe having a proximal end, a distal end adapted fortransurethral insertion into the bladder, and a first electrode near thedistal end. A second probe has a proximal end, a distal end adapted forinsertion into the vagina, and a second electrode near the distal end. Apower source is coupled to the first and second electrodes to heat andshrink the pelvic support tissue. Generally, the first probe will alsoinclude a tordial balloon or other member for sealing around thecircumference of the probe, thereby allowing saline or some otherconductive fluid to be captured within the bladder. In some embodiments,in-flow and out-flow ports distal of the balloon may allow circulationof chilled saline or the like, enhancing the direct cooling of thebladder wall. One or more gas ports may also be provided distal of theballoon for introducing and/or controlling a volume of air, CO₂ or someother insulating gas, or such gasses may alternatively pass through theconductive fluid ports. By carefully controlling the volumes of air andsaline within the bladder, and by orienting the patient so that thesaline is only in contact with the bladder wall adjacent the endopelvicfascia, such a structure can provide both selective electricalconduction and cooling over a large, controlled surface of the bladderwall with very little mechanical complexity or trauma.

In general, the tissue contraction energy of the present invention canbe applied as intermittent pulses of radiofrequency (RF) electricalcurrent transmitted between cooled electrodes. The electrodes willideally be large, relatively flat plates having rounded edges, but mayalternatively comprise a curved conductive surface of an inflatableballoon, or the like. These electrodes will preferably be orientedtoward each other, and will generally be actively cooled while theelectrodes are energized by a RF potential, and between RF pulses.Cooling will preferably also be provided both before and after theheating cycles, and needle mounted temperature sensors will ideallyprovide direct feedback of the tissue temperature so that selectedtreatment zone is heated to about 60° C. or more, while heating of thetissues adjacent the electrodes is limited to about 45° C. or less.

In one aspect, the present invention provides a method for heatingand/or shrinking a target tissue within a patient body. The targettissue is separated from a tissue surface by an intermediate tissue. Themethod comprises coupling an electrode of a probe to the tissue surfaceand cooling the intermediate tissue with the probe. The electrode isintermittently energized to heat, and preferably to shrink, the targettissue through the cooled intermediate tissue. Typically, current isdriven through the electrode for between about 10 and 50% of a heatingsession. For example, the electrode may be energized for 15 secs. andturned off for 15 secs. repeatedly during a heating session so thatcurrent is driven from the electrode for about 50% of the duty cycle.

In another aspect, the invention provides a system for shrinking atarget tissue of a patient body. The system comprises a probe having afirst electrode for electrically coupling the probe to the tissuesurface. A second electrode can be coupled to the patient body, and acontroller is coupled to the first and second electrodes. The controlleris adapted to intermittently energize the electrodes with an RF currentso that the electrodes heat and shrink the target tissue, often whileminimizing collateral damage to tissues surrounding the target tissue.In many embodiments, The target tissue is separated from a tissuesurface by an intermediate tissue. A cooling system may be disposedadjacent the electrode, so that the cooling system can maintain theintermediate tissue below a maximum safe temperature. Generally, thecooling system will cool both the first electrode and the intermediatetissue engaged by the electrode surface.

As described above, the energy to heat and selectively shrink the targetcollagenated support tissues will preferably be applied by conductingradiofrequency (RF) electrical current through tissue disposed betweenlarge, cooled plate electrodes. These electrodes will preferably besufficiently parallel to each other and in alignment so as to direct thecurrent flux evenly throughout a target region of the target tissue. Tomaintain this alignment, the electrodes will generally be mechanicallycoupled to each other, ideally using a clamp structure which allows thetarget tissue to be compressed between the electrode surfaces.Compressing the tissues can enhance the uniformity of the heating,particularly when the tissue is compressed between the electrodesurfaces so that the surfaces are separated by less than their widths.Cooling of the electrodes can limit heating of tissues adjacent theelectrode surfaces to about 45° C. or less, even when the treatment zonebetween the electrodes is heated to about 60° C. or more so as to effectshrinkage.

In this aspect, the present invention provides a device fortherapeutically heating tissue. The device comprises a first electrodehaving an electrode surface. A cooling system is thermally coupled tothe first electrode. A second electrode is mechanically coupled to thefirst electrode. The second electrode has an electrode surface orientedtoward the first electrode surface.

Generally, a clamp structure couples the electrodes and allows thetissues to be compressed between parallel electrode surfaces. The clampstructure will often be adapted to maintain the electrode surfaces inalignment to each other, and also to maintain the electrode surfacessufficiently parallel so as to direct an even electrical current fluxthrough a target region of the clamped tissue. At least one of theelectrodes will preferably be mounted on a probe adapted for insertioninto a patient body. The probe will ideally be adapted for noninvasiveinsertion into a body cavity through a body orifice. The clamp structurewill preferably vary a separation distance between electrodes mounted ontwo such probes, and a temperature sensor will ideally be extendableinto the target tissue to provide feedback on the heating process. Thetemperature sensor can be mounted on a needle which is retractablyextendable from adjacent one of the electrodes toward the other, or theneedle may protrude permanently so as to extend into the target tissueas the electrode surfaces are clamped together.

In another aspect, the present invention provides a method forselectively shrinking a target tissue. The method comprises clamping atarget tissue between a plurality of electrode surfaces. The clampedtarget tissue is heated by transmitting a current flux between theelectrode surfaces. At least one of the electrode surfaces is cooled tolimit heating of intermediate tissue disposed between the at least oneelectrode and the target tissue.

According to another aspect of the invention, the energy can be in theform of focused ultrasound energy. Such ultrasound energy may be safelytransmitted through an intermediate tissue at lower power densities soas to avoid and/or minimize collateral damage. By focusing theultrasound energy at a target region which is smaller in cross sectionthan the ultrasound energy transmitter, the power densities at thetarget region will be sufficiently high to increase the temperature ofthe target tissue. Preferably, the target tissue will be raised to atemperature of about 60° C. or more, while the intermediate tissueremains at or below a maximum safe temperature of about 45° C. A coolingsystem may actively cool the intermediate tissue.

Targeting flexibility is enhanced by using a phased array ultrasoundtransmitter. Such phased array transmitters will be particularlybeneficial for selectively shrinking fascia, ligaments, and other thinsupport tissues of the body, particularly where those tissues aredisposed roughly parallel to an accessible tissue surface. Focusedultrasound energy is particularly well suited for heating and shrinkingthe pelvic support tissues from a vaginal probe.

In this aspect, the present invention provides a method for heating atarget tissue within a patient body. The target tissue is separated froma tissue surface by an intermediate tissue. The method comprisesacoustically coupling an ultrasound transmitter to the tissue surface.The ultrasound energy is focused from the transmitter, through theintermediate tissue, and onto the target tissue so that the targettissue is therapeutically heated. Preferably, the focused ultrasoundenergy heats and shrinks a collagenated tissue. In the exemplaryembodiment of the present method, the ultrasound transmitter is insertedinto a vagina of the patient body to shrink an endopelvic support tissueso that incontinence is inhibited.

In another aspect, the present invention provides a system for heating atarget tissue. The system comprises a probe having an ultrasoundtransmitter for focusing ultrasound energy through the intermediatetissue so as to heat the target tissue. Preferably, a temperature sensoris coupled to the probe and exposed to at least one of the intermediatetissue and the target tissue for sensing a tissue temperature. In manyembodiments, a controller is coupled to the probe. The controller willgenerally be adapted to direct the ultrasound energy from thetransmitter into the target tissue so as to heat the target tissue toabout 60° C. or more. The controller will typically limit a temperatureof the intermediate tissue to about 45° C. or less.

In yet another aspect, the present invention provides a method forselectively heating a predetermined target tissue. The target tissue isdisposed adjacent another tissue, and the method comprises generating atemperature differential between the adjacent tissue and the targettissue. The target tissue is heated by conducting a heating electricalcurrent into the target tissue after generating the temperaturedifferential. The heating current is conducted so that the temperaturedifferential urges the heating current from the adjacent tissue into thetarget tissue.

In a related aspect, the invention provides a system for selectivelyheating a predetermined target tissue. The target tissue is disposedadjacent another tissue, and the system comprises a probe having asurface oriented for engaging a tissue surface. A pre-cooler or apre-heater is coupled to the probe surface so as to produce atemperature differential between the target tissue and the adjacenttissue. At least one tissue-heating electrode is couplable to the targettissue to conduct an electrical current into the tissues. The heatingelectrode defines a nominal current distribution when the current isconducted into the tissues and the tissues are at a uniform bodytemperature. The heating electrode produces a tailored currentdistribution when the current is conducted into the tissues and thetissues exhibit the temperature differential. The tailored currentdistribution results in less collateral damage to the adjacent tissuethan the nominal current distribution when the target tissue is heatedby the current to a treatment temperature.

In a final aspect, the invention provides a probe for selectivelyheating a target tissue. The target tissue is separated from a tissuesurface by an intermediate tissue. The probe comprises a surfaceoriented for engaging the tissue surface. A pair of bi-polar electrodesare disposed along the probe surface. A cooling system is thermallycoupled to the electrodes and to the probe surface, adjacent theelectrodes, so as to cool the intermediate tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a system for heating and shrinkingfascia disposed between adjacent tissue layers by heating the fasciabetween a pair of large, cooled, flat electrode arrays, according to theprinciples of the present invention.

FIG. 2 schematically illustrates the even heating provided by a currentflux between the large, cooled, flat electrode surfaces of the system ofFIG. 1.

FIGS. 2A-2F schematically illustrate structures and methods forselectively energizing the electrode surface segments of the large, flatelectrode arrays of the system of FIG. 1 to tailor the current fluxthroughout a target zone.

FIGS. 3-3E graphically illustrate a method for heating a target tissuebetween cooled electrodes, wherein the electrode surfaces cool thetissue before, during, and after radiofrequency energy is applied.

FIG. 4 is a cut-away view illustrating pelvic support structures whichcan be targeted for non-invasive selective contraction using the methodsof the present invention.

FIGS. 4A-4C illustrate contraction and reinforcing of the pelvic supporttissues of FIG. 4 as a therapies for female urinary incontinence.

FIG. 5 is a perspective view of a system for treating female urinaryincontinence by selectively shrinking the endopelvic fascia, accordingto the principles of the present invention.

FIG. 6 is a cross-sectional view illustrating a method for using thesystem of FIG. 5 to treat female urinary incontinence.

FIG. 7 illustrates an alternative bladder electrode structure for use inthe method of FIG. 6.

FIGS. 8A and 8B illustrate an alternative vaginal probe having a balloondeployable electrode for use in the method of FIG. 6.

FIG. 9 is a cross-sectional view illustrating a structure and a methodfor ultrasonically positioning a temperature sensor within a targettissue.

FIG. 10 illustrates an alternative system for selectively shrinkingfascia through intermediate tissues, according to the principles of thepresent invention.

FIG. 11 schematically illustrates an alternative method for selectivelyshrinking endopelvic fascia using a vaginal probe having a cooledelectrode array and a return electrode.

FIG. 12 schematically illustrates cooled bipolar probe and a method forits use to selectively shrink endopelvic fascia by applying a bipolarpotential between electrode segments of the probe, the method includingelectrically insulating a surface of the endopelvic fascia opposite theprobe to limit the depth of heating.

FIGS. 12A-L illustrate a variety of cooled bi-polar probes and methodsfor their use to selectively heat tissues separated from the probe by anadjacent tissue.

FIG. 13 schematically illustrates a method for selectively shrinkingendopelvic fascia by transmitting microwave or ultrasound energy from acooled vaginal probe.

FIGS. 13A-M illustrate alternative focused ultrasound probes forremotely heating tissues, the probes having phased array ultrasoundtransmitters with either an annular or linear array geometry.

FIG. 14 is a cross-sectional view illustrating a method for selectivelyshrinking endopelvic fascia by grasping and folding the wall of thevagina or colon to facilitate focusing of heating upon the fascia, andto enhance shrinkage of the fascia by decreasing tension in the fasciawhile the fascia is heated, according to the principles of the presentinvention.

FIG. 15 is a schematic illustration of a kit including the vaginal probeof FIG. 5, together with instructions for its use to shrink tissues,according to the methods of the present invention.

FIGS. 16A-C illustrate structures and methods for selectivelytransmitting an RF current flux through a conductive fluid within thebladder while cooling the bladder wall with the fluid, according to theprinciples of the present invention.

FIGS. 17A and B illustrate an alternative probe for use with aconductive fluid, the probe having both a toroidal balloon for sealingthe conductive fluid and an insulating gas within the bladder, and aspoon shaped balloon supporting an electrode surface, whereby theendopelvic fascia between the bladder electrode and a cooled plateelectrode of a vaginal probe may be heated and shrunk.

FIGS. 18A-C illustrates a clamping structure having a transvaginal probeand a transrectal probe, in which each of the probes includes anelectrode surface, and in which the probes are mechanically coupled by aclamping structure for compressing the targeted endopelvic fascia(together with intermediate tissues) between a pair of opposed, cooledplate electrodes.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention optionally relies on inducing controlled shrinkageor contraction of a support tissue of the body, typically being acollagenated tissue such as fascia, ligament, or the like. For treatmentof urinary incontinence, the tissue structure will be one that isresponsible in some manner for control of urination, or for supporting asuch a tissue. Exemplary tissue structures include the urethral wall,the bladder neck, the bladder, the urethra, bladder suspensionligaments, the sphincter, pelvic ligaments, pelvic floor muscles,fascia, and the like. Treatment of other conditions may be effected byselective shrinking of a wide variety of other tissues, including (butnot limited to) the diaphragm, the abdominal wall, the breast supportingligaments, the fascia and ligaments of the joints, the collagenatedtissues of the skin, and the like. Related devices, methods, and systemare also described in co-pending U.S. patent application Ser. No.08/910,370 filed Aug. 13, 1997.

Tissue contraction results from controlled heating of the tissue byaffecting the collagen molecules of the tissue. Contraction occurs as aresult of heat-induced uncoiling and repositioning of the collagenâ-pleated structure. By maintaining the times and temperatures set forthbelow, significant tissue contraction can be achieved withoutsubstantial collateral tissue damage.

The temperature of the target tissue structure will generally be raisedto a value in the range from about 60° C. to 110° C., often being in therange from about 60° C. to 80° C., and will generally effect a shrinkageof the target tissue in at least one dimension of between about 20 and50 percent. In many embodiments, heating energy will be applied for aperiod of from 30 seconds to 5 minutes. These heating times will varywith separation between the parallel plate electrodes, with a heat timeof about 5 minutes often being appropriate for an electrode separationof about 4 cm. Shorter heat times may be used with smaller electrodeseparation distances.

The rise in temperature may be quite fast, although there will often beadvantages in heating tissues more slowly, as this will allow more heatto be removed from tissues which are not targeted for therapy, therebyminimizing collateral damage. However, if too little heating energy isabsorbed by the tissue, blood perfusion will transfer the heat away fromthe targeted tissue, so that the temperature will not rise sufficientlyto effect therapy. Fortunately, fascia and other support tissues oftenhave less blood flow than adjacent tissues and organs; this may helpenhance the heating of fascia and minimize damage to the surroundingstructures.

The total amount of energy delivered will depend in part on which tissuestructure is being treated, how much tissue is disposed between thetarget tissue and the heating element, and the specific temperature andtime selected for the protocol. The power delivered will often be in therange from 10 W to 200 W, usually being about 75 W. The temperature willusually not drop instantaneously when the heating energy stops, so thatthe tissue may remain at or near the therapy temperature for a time fromabout 10 seconds to about 2 minutes, and will often cool gradually backto body temperature.

While the remaining description is generally directed at devices andmethods for treatment of urinary stress incontinence of a femalepatient, it will be appreciated that the present invention will findmany other applications for selectively directing therapeutic heatingenergy into the tissues of a patient body for shrinking of tissues, forablation of tissues and tumors, and the like.

FIG. 1 schematically illustrates a system 10 for shrinking a fascia Fdisposed between first and second adjacent tissues T1, T2. System 10includes a pair of electrodes 12, 14 having large, substantially planartissue engaging surfaces. Electrodes 12, 14 are aligned substantiallyparallel to each other with the fascia (and adjacent tissues) disposedtherebetween.

The surfaces of electrodes 12, 14 which engage the tissue are cooled bya cooling system 16. The cooling system will typically include a conduitthrough the electrode for the circulation of a cooling fluid, but mayoptionally rely on thermoelectric cooling or the like. The temperatureof the electrode surface may be regulated by varying the temperature orflow rate of the cooling fluid. Cooling may be provided through the useof an ice bath, by endothermic chemical reactions, by standard surgicalroom refrigeration mechanisms, or the like. Ideally, the cooling systemcools an area which extends beyond the energized electrode surfaces toprevent any hot spots adjacent the tissue surface, and to maximize theheat removal from the tissue without chilling it to or belowtemperatures that irreversibly damage the tissue, such as might occurwhen freezing the tissue.

Each of the electrodes is separated into a plurality of electrodesegments. For example, the electrode includes electrode segments 12 a,12 b, 12 c, 12 d, and 12 e, each of which is electrically isolated fromthe others. This allows the electrode segments to be individuallyenergized.

Electrodes 12, 14 are energized by a radiofrequency (RF) power source18. Multiplexers 20 individually energize each electrode segment,typically varying the power or time each segment is energized to morenearly uniformly heat fascia F. A controller 22 will typically include acomputer program which directs the application of cooling flow and RFpower through electrodes 12, 14, ideally based at least in part on atemperature signal sensed by a temperature sensor 24. Temperature sensor24 may sense the temperature of the electrode, the tissue at thetissue/electrode interface, the intermediate tissue, or mayalternatively sense the temperature of the fascia itself. Alternatively,the controller may direct the cooling/heating therapy in an open loopmanner using dosimetry.

The use of large cooled plate electrodes to direct an even electricalcurrent flux can be understood with reference to the simplifiedcross-sectional illustration of FIG. 2. In this example, RF power isapplied uniformly across parallel plate electrodes 12, 14 to produce acurrent through tissue T. As the electrode surfaces are substantiallyplanar, and as the length and width of the electrode surfaces are largecompared to the separation between the electrodes, a current flux 26 issubstantially uniform throughout that portion of the tissue which isdisposed between the electrode surfaces. The flow of electrical currentthrough the electrical resistance of the tissue causes the temperatureof the tissue through which the current passes to rise. The use of aradiofrequency current of relatively low voltage, preferably in therange from 100 kHz to 1 MHz, helps to avoid arcing and damage to tissuein direct contact with the electrodes.

Preliminary work in connection with the present invention has shown thatfascia and other collagenated tissues which are heated to a temperaturerange of between about 60° C. and 140° C., often being in a range fromabout 60° C. to about 110° C., and preferably between about 60° C. and80° C., will contract. In fact, unstressed fascia will shrink betweenabout 30% and 50% when heated for a very short time, preferably frombetween about 0.5 seconds to 5 seconds. Such heating can easily beprovided by conduction of RF currents through the tissue.

The uniform current flux provided by the large plate electrodes of thepresent invention will produce a substantially uniform heating of thetissue which passes that current. To selectively target a centralportion of the tissue, in other words, to selectively heat a targetportion of the tissue separated from electrodes 12, 14, the electrodesurfaces are cooled. This cooling maintains a cooled tissue region 28adjacent each electrode below a maximum safe tissue temperature,typically being below about 45° C. Even though heat generationthroughout the gap between the electrodes is uniform, the temperatureprofile of the tissue between the electrodes can be controlled byremoving heat through the electrode surfaces during heating.

Generally, sufficient heating can be provided by a current of betweenabout 0.2 and 2.0 amps, ideally about 1.0 amp, and a maximum voltage ofbetween about 30 and 100 volts rms., ideally being about 60 volts rms.The electrodes will often have a surface area of between about 5.0 and200 cm², and the current density in the target tissue will often bebetween about 1 mA/cm² and 400 mA/cm², preferably being between about 5mA/cm² and 50 mA/cm². This will provide a maximum power in the rangefrom about 10 W to about 200 W, often being about 20 watts. Using suchlow power settings, if either electrode is lifted away from the engagedtissue, there will be no arcing. Instead, the current will simply stop.This highlights the difference between the electrical tissue heating ofthe present invention and known electrosurgical techniques.

The ideal geometry to provide a true one-dimensional temperaturedistribution would include large parallel plate electrodes havingrelatively minimal spacing therebetween. As tissues which are easilyaccessible for such structures are fairly limited, the present inventioncan also make use of electrode geometries which vary somewhat from thisideal, particularly through the use of array electrodes. In fact, theuse of a single array electrode, in combination with a much larger,uncooled electrode pad may heat tissues disposed near the array, as willbe described hereinbelow. Nonetheless, uniform heating is generallyenhanced by providing electrode structures having tissue engagingsurfaces which are as flat and/or as parallel as practical. Preferably,the parallel electrode surfaces will be separated by between about ⅓ and5.0 times the width of the electrode surfaces (or of the smallersurface, if they are different).

The use of an array electrode having multiple electrode segments can beunderstood with reference to FIGS. 2A-2D. FIG. 2A schematicallyillustrates the shape of a target zone which is heated by selectivelyenergizing only electrode segments 12 c and 14 c of cooled electrodes 12and 14. Once again, it should be understood that the temperature oftarget zone 32 (here illustrated schematically with isotemperaturecontour lines 30) is the result of uniform heating between the energizedelectrode segments, in combination with cooling of tissue T by theelectrode surfaces. To expand the heated area laterally between theelectrodes, electrode segments 12 a, 12 b, 12 c . . . , and 14 a, 14 b,14 c . . . , can be energized, thereby heating an entire target zone 32extending throughout tissue T between the electrodes.

The use of array electrodes provides still further flexibility regardingthe selective targeting of tissues between electrodes 12 and 14. Asillustrated in FIG. 2C, selectively energizing a relatively largeeffective electrode surface by driving electrodes segments 12 a, 12 b,12 c, 12 d, and 12 e results in a low current flux which is widelydisbursed throughout the tissue T engaged by electrode 12. By drivingthis same current through a relatively small effective electrode surfaceusing only a single electrode surface segment 14 c produces an offsettarget zone 34 which is laterally smaller than and much closer toelectrode 14 than to electrode 12.

To compensate for electrode structures which are not exactly parallel,varying amounts of electrical current can be provided to the electrodesegments. For example, a fairly uniform target zone 32 may be heatedbetween angled electrodes by driving more current through relativelywidely spaced electrode segments 12 a, 14 a, and driving less currentthrough more tightly spaced electrode segments 12 e, 14 e, asillustrated in FIG. 2D. Alternatively, the same current may be drivenbetween the segments, but for different intermittent duty cycles. Itshould be understood that these selective targeting mechanisms may becombined to target fascia and other tissues which are near one slantedelectrode, or to selectively target only a portion of the tissuesdisposed between relatively large electrode arrays.

An exemplary structure for segmented, cooled electrode 12 isschematically illustrated in FIGS. 2E and F. Electrode 12 here comprisesthree electrode surface segments 12 a, 12 b, and 12 c separated byinsulating spaces 21. A plastic housing 23 defines a flow path between acooling inflow port 25 and a cooling outflow port 27, while heattransfer between the cooling fluid and the electrode surface is enhancedby a thermally conductive front plate 29. Front plate 29 generallycomprises a thermally conductive metal such as aluminum. Electrodesurface segments 12 a, 12 b, and 12 c may comprise surfaces of separatedsegments 31 of aluminum foil. Segments 31 may be electrically isolatedand thermally coupled by a thin mylar insulation sheet 33 disposedbetween the segments and front plate 29.

The array electrode structures of the present invention will generallyinclude a series of conductive surface segments which are aligned todefine a substantially flat electrode surface. The electrode surfacesegments are separated by an electrically insulating material, with theinsulation being much smaller in surface area than the conductivesegments. Typically, there will be between 1.0 and 8.0 electrodesegments, which are separated by a distance of between about 0.25 mm and1.0 mm.

In some embodiments, the peripheral edges of the electrode segments maybe rounded and/or covered by an insulating material to preventconcentrations of the electrical potential and injury to the engagedtissue surfaces.

It should also be understood that while the electrode arrays of thepresent invention are generally herein described with reference to alinear array geometry, the present invention also encompasses electrodeswhich are segmented into two-dimensional arrays. Where opposed sides ofthe tissue are accessible for relatively large array structures, such asalong the exposed skin, or near the major cavities and orifices of thebody, the electrode surfaces will preferably be separated by a gap whichis less than a width (and length) of the electrodes.

In some embodiments, one electrode structure may be disposed within alarge body cavity such as the rectum or vagina, while the other isplaced in an adjacent cavity, or on the skin so that the region to betreated is between the electrode surfaces. In other embodiments, one orboth electrodes may be inserted and positioned laparoscopically. It willoften be desirable to clamp the tissue tightly between the electrodes tominimize the gap therebetween, and to promote efficient coupling of theelectrode to the tissue.

As can be understood with reference to FIGS. 3-3E, the tissue willpreferably be cooled before and after energizing of the electrodes. FIG.3 illustrates three distinct regions of tissue T disposed betweenelectrodes 12 and 14. Target zone 32 will typically comprise fascia orsome other collagenated tissue, while the surfaces of the electrodesengage an intermediate tissue 36 disposed on either side of the fascia.

It will generally be desirable to maintain the temperature ofintermediate tissue 36 below a maximum safe tissue temperature toprevent injury to this intermediate tissue, the maximum safe tissuetemperature typically being about 45° C. To effect shrinkage of fascia,target zone 32 will typically be heated to a temperature above about 60°C., and often to a temperature at or above 70° C.

There will often be a region of stunned tissue 38 disposed between thesafely cooled intermediate tissue 36 and the target zone 32. Thisstunned tissue will typically be heated in the range from about 45° C.to about 60° C., and may therefore undergo some limited injury duringthe treatment process. As a result, it is generally desirable tominimize the time this tissue is at an elevated temperature, as well asthe amount of stunned tissue.

As illustrated in FIG. 3A, prior to application of cooling or heatingenergy, the temperature profile of tissue T along an axis X betweenelectrodes 12 and 14 is substantially uniform at body temperature(approximately 37° C.). The tissue will preferably be pre-cooled by thesurfaces of electrodes 12, 14, generally using an electrode surfacetemperature of at or above 0° C. Pre-cooling will substantially decreasethe temperature of intermediate tissues 36, and will preferably at leastpartially decrease the temperature of stunned tissue 38. At least aportion of the target zone remains at or near the initial bodytemperature, as illustrated in FIG. 3B. Pre-cooling time will oftendepend on electrode separation and tissue heat diffusivity.

As will be explained in more detail regarding FIGS. 12-12L, pre-cooling(and/or pre-heating) of selective portions of the tissue engaged by acooled electrode can alter the electrical current densities withintissues so as to provide selective, localized heating. Referring to FIG.3B, intermediate tissue 36 exhibits a substantial temperaturedifferential as compared to target tissue 32. As a result of thistemperature differential, the electrical impedance of an immediatetissue 36 has been enhanced relative to target tissue 32. This does notnecessarily mean that the impedance of the intermediate tissue is nowgreater than that of the target tissue (although this will often be thecase). Regardless, as compared to the tissues at uniform bodytemperature, the temperature differential between the target andintermediate tissues can now be used to help enhance selective heatingof the target tissue while minimizing collateral damage to the adjacenttissue.

Once the tissue has been pre-cooled, the RF current is directed throughthe tissue between the electrodes to heat the tissue. A temperaturesensor can be placed at the center of target zone 32 to help determinewhen the pre-cooling has been applied for the proper time to initiate RFheating. The current flux applies a fairly uniform heating throughoutthe tissue between the electrodes, and the electrode surfaces are oftencooled throughout the heating process. As target zone 32 has the highesttemperature upon initiation of the heating cycle, and as the target zoneis farthest from the cooled electrodes, a relatively small amount ofheat flows from the target zone into the cooled electrodes, and thetarget zone is heated to a significantly higher temperature thanintermediate tissue 36.

Heat is applied until the target zone is at or above a treatmenttemperature, typically resulting in a temperature distribution such asthat illustrated in FIG. 3C. To minimize collateral damage to theadjacent tissues 36 and stunned tissue 38, the cooling system continuesto circulate cold fluid through the electrode, and to remove heat fromthe tissue, after the heating radiofrequency energy is halted. Whensubstantially the entire tissue is below the maximum safe tissuetemperature (as in FIG. 3D), cooling can be halted, and the tissue canbe allowed to return to standard body temperature, as illustrated inFIG. 3E.

Optionally, RF current may be driven between the two cooled plateelectrodes using intermittent pulses of excitation. As used herein,intermittent or pulsed excitation encompasses cyclically increasing anddecreasing delivered power, including cyclical variations in RMS powerprovided by amplitude modulation, waveform shape modulation, pulse widthmodulation, or the like. Such intermittent excitation will preferablyprovide no more than about 25% of the RMS power of the pulses during theintervals between pulses. Preferably, the electrodes will be energizedfor between about 10 and 50% of a total heating session. For example,electrodes 12 and 14 may be energized for 15 secs. and then turned offfor 15 secs. and then cycled on and off again repeatedly until thetarget tissue has been heated sufficiently to effect the desiredshrinkage. Preferably, the electrode surfaces (and the surrounding probestructure which engages the tissue) will be cooled throughout the on/offcycles of the heating sessions.

The therapeutic heating and cooling provided by the electrodes of thepresent invention will often be verified and/or controlled by sensingthe temperature of the target tissue and the adjacent tissue directly.Such temperature sensing may be provided using a needle containing twotemperature sensors: one at the tip to be positioned at the center ofthe treatment zone, and the second along the shaft of the needle so asto be positioned at the edge of the desired protection zone. In otherwords, the second sensor will be placed along the border between theintermediate tissue and the target tissue, typically somewhere alongstunned tissue 38. The temperature sensors will preferably sense thetissue temperature during the intervals between pulses to minimizeerrors induced by the heating RF current flux in the surrounding tissue.The temperature sensors may comprise thermistors, thermocouples, or thelike.

The temperature sensing needle may be affixed to or advancable from aprobe supporting the electrode adjacent to or between the electrodesegments. Alternatively, two or more needles may be used. Typically,controller 22 will provide signals to cooling system 16 and theelectrodes so that the electrodes chill the engaged tissue continuallywhile the RF current is pulsed to increase the temperature of thetreatment zone incrementally, ideally in a step-wise manner, until itreaches a temperature of 60° C. or more, while at the same time limitingheating of the intermediate tissue to 45° C. or less per the feedbackfrom the needles.

In alternative embodiments, pre-chilling time, the duration of the heat,the lengths of the heating intervals (and the time between heatingintervals) during intermittent heating, and the radiofrequency heatingcurrent may be controlled without having direct feedback by usingdosimetry. Where the thermal properties of these tissues aresufficiently predictable, the effect of treatment can be estimated fromprevious measurements.

The pelvic support tissues which generally maintain the position of theurinary bladder B are illustrated in FIG. 4. Of particular importancefor the method of the present invention, endopelvic fascia EF defines ahammock-like structure which extends between the arcus tendineus fasciapelvis ATFP. These latter structures extend between the anterior andposterior portions of the pelvic bone, so that the endopelvic fascia EFlargely defines the pelvic floor.

In women with urinary stress incontinence due to bladder neckhypermobility, the bladder has typically dropped between about 1.0 cmand 1.5 cm (or more) below its nominal position. This condition istypically due to weakening of the pelvic support structures, includingthe endopelvic fascia, the arcus tendineus fascia pelvis, and thesurrounding ligaments and muscles, often as the result of bearingchildren.

When a woman with urinary stress incontinence sneezes, coughs, laughs,or exercises, the abdominal pressure often increases momentarily. Suchpressure pulses force the bladder to descend still further, shorteningthe urethra UR and momentarily opening the urinary sphincter.

As can be most clearly understood with reference to FIGS. 4A-4C, thepresent invention generally provides a therapy which applies gentleheating to shrink the length of the support tissues and return bladder Bto its nominal position. Advantageously, the bladder is still supportedby the fascia, muscles, ligaments, and tendons of the body. Using gentleresistive heating between bipolar electrodes, the endopelvic fascia EFand arcus tendineus fascia pelvis ATFP are controllably contracted toshrink them and re-elevate the bladder toward its original position.

Referring now to FIG. 4A, bladder B can be seen to have dropped from itsnominal position (shown in phantom by outline 36). While endopelvicfascia EF still supports bladder B to maintain continence when thepatient is at rest, a momentary pressure pulse P opens the bladder neckN, resulting in a release through urethra UR.

A known treatment for urinary stress incontinence relies on sutures S tohold bladder neck N closed so as to prevent inadvertent voiding, as seenin FIG. 4B. Sutures S may be attached to bone anchors affixed to thepubic bone, ligaments higher in the pelvic region, or the like. In anycase, loose sutures provide insufficient support of the bladder neck Nand fail to overcome urinary stress incontinence, while overtighteningof sutures S may make normal urination difficult and/or impossible.

As shown in FIG. 4C, by selectively contracting the natural pelvicsupport tissues, bladder B can be elevated from its lowered position(shown by lowered outline 38). A pressure pulse P is resisted in part byendopelvic fascia EF, which supports the lower portion of the bladderand helps maintain the bladder neck in a closed configuration. In fact,fine tuning of the support provided by the endopelvic fascia is possiblethrough selective contraction of the anterior portion of the endopelvicfascia to close the bladder neck and raise bladder B upward.Alternatively, lateral repositioning of bladder B to a more forwardposition may be affected by selectively contracting the dorsal portionof endopelvic fascia EF. Hence, the therapy of the present invention maybe tailored to the particular elongation exhibited by a patient's pelvicsupport tissues.

As is more fully explained in published PCT Patent ApplicationPublication No. WO 97/20191, a wide variety of alternative conditionsmay also be treated using the methods of the present invention. Inparticular, selective shrinkage of fascia may effectively treatcystocele, hiatal, and inguinal hernias, and may even be used incosmetic procedures such as abdominoplasty (through selectivelyshrinking of the abdominal wall), to remove wrinkles by shrinking thecollagenated skin tissues, or to lift sagging breasts by shrinking theirsupport ligaments.

A system for selectively shrinking the endopelvic fascia is illustratedin FIG. 5. System 40 includes a vaginal probe 42 and a bladder probe 44.Vaginal probe 42 has a proximal end 46 and a distal end 48. Electrode 12(including segments 12 a, 12 b, 12 c, and 12 d) is mounted near thedistal end of the probe. Vaginal probe 42 will typically have a diameterof between about 2 and 4 cm, and will often have a shaft length ofbetween about 6 and 12 cm. An electrical coupling 50 is coupleable to anRF power supply, and optionally to an external control processor.Alternatively, a controller may be integrated into the probe itself. Afluid coupling 52 provides attachment to a cooling fluid system. Coolingfluid may be recycled through the probe, so that more than one fluidcouplers may be provided.

The segments of electrode 12 are quite close to each other, andpreferably define a substantially flat electrode surface 54. The coolingfluid flows immediately below this surface, the surface materialpreferably being both thermally and electrically conductive. Ideally,surface 54 is as large as the tissue region to be treated, and athermocouple or other temperature sensor may be mounted adjacent thesurface for engaging the tissue surface and measuring the temperature ofthe engaged tissue.

Urethral probe 44 includes a balloon 56 supporting a deployableelectrode surface. This allows the use of a larger electrode surfacethan could normally be inserted through the urethra, by expanding theballoon structure within the bladder as illustrated in FIG. 6.Alternatively, a narrower cylindrical electrode might be used whichengages the surrounding urethra, the urethral electrode optionally beingseparated into more than one segment along the length and/or around thecircumference of the probe shaft. Radiofrequency current will divertfrom such a tightly curved surface and heat the nearby tissue. Theelectrode can again be chilled to protect the urethral lining fromthermal damage. Probe 44 may include a temperature measuring device toensure that the temperature of the intermediate tissue does not riseabove 45° C. adjacent the electrode.

As illustrated in FIG. 6, the endopelvic fascia will preferably bedisposed between the electrodes of the urethral probe 44 and vaginalprobe 42 when the vaginal probe is levered to the right or the left sideof the pelvis by the physician. Balloon 56 of urethral probe 44 is hereillustrated in its expanded configuration, thereby maximizing a surfacearea of electrode 14, and also minimizing its curvature (or in otherwords, minimizing the radius of curvature of the electrode surface).Preferably, cooled fluid recirculating through balloon 56 will coolelectrode 14, so that cooled electrodes 12, 14 will selectively heat theendopelvic fascia EF without damaging the delicate vaginal wall VW orthe bladder wall.

Urethral probe 44 and vaginal probe 42 may optionally be coupleable toeach other to facilitate aligning the probes on either side of thetarget tissue, either mechanically or by some remote sensing system. Forexample, one of the probes may include an ultrasound transducer, therebyfacilitating alignment of the electrode surfaces and identification ofthe target tissue. Alternatively, the proximal ends of the probes mayattach together to align the electrodes and/or clamp the target tissuebetween the probes.

In some embodiments, cooled fluid may be recirculated through bladder Bso as to cool the bladder wall without conducting electrical heatingcurrent from within the bladder. Optionally, such a cooling fluid flowmay be provided within balloon 56. Alternatively, the cooling fluid flowcould be recirculated within the bladder cavity in direct contact withthe bladder wall. Such a cooling flow might be provided with a two lumen(an inflow lumen and an outflow lumen) catheter, the catheter optionallyhaving a sealing member (such as a toroidal balloon around the catheter)to contain the cooling fluid within the bladder once the catheter isinserted through the urethra. Such a cooling flow can help limit thedepth of tissue heating when using a monipolar transvaginal probe, orwhen using a bipolar probe such as those described in FIGS. 12-12L.

Referring now to FIG. 7, a mesh electrode 58 may be unfurled within thebladder in place of urethral probe 44. Mesh electrode 58 preferablycomprises a highly flexible conductive element, optionally being formedof a shape memory alloy such as Nitinol™. The bladder may be filled withan electrically non-conductive fluid such as distilled water during thetherapy, so that little or no RF current would flow into the bladderwall beyond the contact region between the electrode and the bladder. Tolimit heating of tissues which are disposed above the bladder, an upperportion 58 of the mesh structure may be masked off electrically from theenergized mesh surface of the lower portion.

FIGS. 8A and 8B illustrate an optional deployable electrode supportstructure for use with vaginal probe 42. Electrode 12 can be collapsedinto a narrow configuration for insertion and positioning within thevaginal cavity, as illustrated in FIG. 8A. Once electrode 12 ispositioned adjacent to the target tissue, electrode 12 can be expandedby inflating lateral balloon 60 so that the deployed electrode assumes asubstantially planar configuration. A cooling fluid may be recirculatedthrough lateral balloon 60 to cool the electrode 12, and a thermallyinsulating layer 62 can help to minimize heat transfer from the adjacenttissues.

Referring now to FIG. 9, the tissue shrinking system of the presentinvention may also include an ultrasonic transducer 64 for positioningone or both electrodes relative to fascia F. Transducer 64 willpreferably include a plastic transducer material such as PVDF(polyvinyladine fluoride) or PZT-5A (lead zirconate titanate).Transducer 64 may be incorporated into the probes of the presentinvention, thereby allowing the relative positions and angle between theelectrode surfaces to be measured directly. Alternatively, transducer 64may be positioned adjacent to fascia F, and a mark may be drawn upon theexposed skin (or other tissue surface) adjacent the fascia forsubsequent positioning of a probe.

Transducer 64 optionally includes a needle guide 66 for insertion of abiopsy needle 68 through the view of the transducer and into the fascia.A thermocouple or other temperature sensing element may then be deployedusing or in place of the biopsy needle.

Referring now to FIG. 10, an alternative tissue shrinking system 70includes an electrode 12 mounted on a speculum 72. Speculum 72 may beused to manually position electrode 12 within the vagina (or anotherbody orifice), while an external applicator 74 is positioned against theskin to clamp the target tissue between electrode 14 and electrode 12.The speculum and external applicator 74 may be manually manipulated toclamp the target tissue between these structures, while electrical leads76 and cooling fluid conduits 78 couple the probe and applicator to theremaining system components.

As described above regarding FIG. 2C, the use of bipolar electrodes ofdiffering sizes allows the selective targeting of tissues. Specifically,heating will be concentrated near the smaller electrode surface. Byusing one electrode surface which is much larger than the other, thecurrent density adjacent the large electrode will remain so low thatlittle tissue heating is produced at that site, so that the very largeelectrode surface need not be cooled. FIG. 11 schematically illustratesa single probe heating system 80 which takes advantage of this mechanismto selectively heat fascia near a single probe.

In single probe system 80, offset target zone 34 is heated by RF energyselectively directed through the segments of electrode 12. The vaginalwall VW disposed between vaginal probe 42 and endopelvic fascia EF isprotected by cooling the surface of electrode 12, as described above.Bladder B (and the other tissues opposite endopelvic fascia EF relativeto vaginal probe 42) are heated significantly less than endopelvicfascia EF due to the divergence of the current as it travels away fromelectrode 12 and towards electrode pad 82, which may optionally bedisposed on the abdomen, back, or thigh. Optionally, cooling water maybe circulated through bladder B to further protect these tissues bydirect cooling and by raising the impedance of the cooled tissue tolower heating (particularly when the bladder wall is pre-chilled priorto heating). Multiplexer 20 selectively energizes the electrode segmentsfor differing amounts of time and/or with differing power to help tailorthe temperature profile of offset target zone 34 about endopelvic fasciaEF for selective uniform heating with minimal collateral damage. Varioustreatment regimes with alternating heating and cooling cycles can helpto focus the heat therapy on the desired tissues. Multiplexer 20 may bedisposed outside of the body in a proximal housing, in a separatecontrol unit housing, or the like. The multiplexer can provide electrodesegment drive control, optionally with switches for each electrodesegment.

Referring now to FIG. 12, a cooled bipolar probe 84 includes many of thestructures and features described above, but here includes a series ofbipolar electrodes 86. Bi-polar electrodes 86 will preferably be cooled,and cooling surfaces may also be disposed between the separatedelectrodes. Bi-polar electrodes 86 may optionally be formed as parallelcylindrical structures separated by a predetermined spacing to helpdirect a bipolar current flux 88 through tissue which lies within aparticular treatment distance of probe 84.

The depth of penetration of the bipolar energy can be controlled by thespacing, size, and shape (i.e., the radius of curvature) of theelectrode structures. The tissues distant from the cooled electrodes canbe heated to a greater extent than the tissues directly engaged by theelectrodes, and will be cooled to a lesser extent by the cooledelectrodes and other cooling surfaces of bipolar probe 84. The tissuesclose to the electrodes can be protected from burning to a greaterextent, and will also be cooled directly and actively. Therefore, acontrolled regimen of timed pre-cooling and then heating is used toselectively raise the temperature of endopelvic fascia EF (or any othertarget tissue), while the vaginal mucosa adjacent probe 84 is protectedby the cooled probe. Tissues at depths greater than the endopelvicfascia will generally be protected by the dissipation of bipolar current88.

Since radiofrequency heating generally relies on conduction ofelectricity through the tissue, one additional mechanism for protectingthe tissues at depths greater than the target area would be to inject aninsulating fluid 90 into the space surrounding the vaginal wall on thefar side of endopelvic fascia EF. Insulating fluid 90 may optionallycomprise a gas such as CO₂, or may alternatively comprise a liquid suchas isotonic Dextran™ in water. Insulating fluid 90 will electricallyinsulate the adjacent organs and prevent heating of tissues that mightotherwise be in contact with the vaginal fascial outer lining.Insulating fluid 90 is here injected using a small needle incorporatedinto bipolar probe 84, the needle preferably being 22 ga or smaller.

A variety of alternative cooled bipolar probe structures are illustratedin FIGS. 12A-L. Referring first to FIGS. 12A-C, a simple cooled bi-polarprobe 84A includes a pair of bi-polar electrodes 86A which are insulatedfrom a probe body by inserts 87. The probe body includes a coolingchannel system 89 which cools electrodes 86A and at least a portion ofthe surrounding surface of the probe body. Surprisingly, by properlyspacing electrodes 86A (typically by a distance from about ⅓ to about 5times the least width of the electrodes, and preferably by a distancefrom about ½ to about 2 times the least electrode width), and byproperly cooling the tissue surface before initiating RF heating;arcing, charring and excessive collateral damage to the engaged tissuesurface can be avoided even when using electrodes having substantiallyplaner electrode surfaces without radiused edges. Rounding the cornersof electrodes 86A may optionally still further minimize concentrationsof electrical current. In many embodiments, cooling channel system 89will include channels adjacent to and/or between the electrodes.Optionally, tissue and/or probe temperature sensors may also beprovided.

Typically, the probe body adjacent the electrodes will comprise athermally conductive material to enhance heat conduction from theengaged tissue surface for pre-cooling of the tissue (and for coolingthe tissue engaging and adjacent the electrodes during RF heating). Thebody may comprise any of a variety of alternative metals such asaluminum or the like, and may comprise a thermal insulation material onthe back and side surfaces. Inserts 87 will ideally comprise thermallyconductive and electrically insulating structures. Inserts 87 mayoptionally comprise a polymer such as Derlin° or the like. In someembodiments, the thickness of inserts 87 will be minimized to enhancethermal conduction while still maintaining sufficient electricalinsulation. For such embodiments, inserts 87 may comprise films of apolymer such as Mylar® or the like, or may be formed in part fromanodized aluminum. Electrodes 86A will typically comprise a thermallyconductive and electrically conductive metal.

In the embodiment illustrated in 12A-C, the probe has an overall lengthof about 3″ and a width of about 2″. Electrodes 86A have a length ofjust under an inch, a width in the range of ⅛″ to ¼″ and are separatedby a distance in a range from about 0.2″ to about ½″.

Referring to FIGS. 12D and E, another cooled bi-polar probe 84B includesa pair of heating electrodes 86B mounted to a cooled probe body.Bi-polar probe 84B also includes a tissue pre-heater in the form ofpre-heat electrodes 91. As can be understood with reference to FIG. 12E,as the cooled probe body draws heat from the engaged tissue surface,conduction of a pre-heating radiofrequency current between pre-heatelectrodes 91 in a bi-polar manner can enhance the temperaturedifferential between the target tissue and the intermediate tissue. Thisallows a probe structure engaging a single tissue surface to approximatethe tissue temperature profile which is desired at the time heating isinitiated (as described above regarding FIG. 3). Additionally, thisenhanced temperature differential may lower the impedance of the targettissue so as to increase the current density in that region. As thecooled intermediate tissue should have a higher impedance, and ascurrent will generally seek the path of least impedance, the pre-warmedtarget tissue can be heated with less collateral damage to the adjacenttissues. Note that in some embodiments, pre-heating might be usedwithout pre-cooling to provide at least a portion of this desiredtemperature differential. Regardless, the temperature differential urgesthe current from the adjacent tissue and into the target tissue. Itshould be noted that a careful monitoring of adjacent tissue and/orsurface impedance can be beneficial. If the impedance of the cooledtissue is raised too much, the current may travel along the surface ofthe probe, rather than penetrating to the target tissue. The surfaceimpedance can be monitored and/or controlled using the surfacetemperature.

This generation of a preferred current path by imposing a temperaturedifferential on the tissue prior to RF heating may be used withpre-coolers, pre-heaters, and heating electrodes having a wide varietyof differing geometries. In general, pre-heating can reduce an impedanceof the target tissue sufficiently to locally enhance current densitysuch that the eventual heating of the target tissue is significantlyincreased. As heating progresses, the temperature differential anddifference in impedance may increase, further reinforcing the selectiveheating of the target tissue with a positive feedback type response. Thepre-heating will often be controlled so as to align the temperaturedifferential between the target tissue and the adjacent tissue.

Similarly, pre-cooling might be used with pre-heating or withoutpre-heating so as to generate the desired temperature differential.Pre-cooling should enhance an impedance of a tissue sufficiently tolocally reduce current density within that tissue so that its heating issignificantly diminished. Pre-cooling will often be controlled to alignthe temperature differential between the target tissue and the adjacenttissue.

In general, localized RF heating will often make use of electricalcurrents which are sufficiently parallel to a boundary region betweenthe target tissue and the intermediate tissue so that the differentialimpedance urges current in the desired direction.

It should be understood that pre-heating might be provided by a widevariety of energy transmitting elements, including the energytransmitting elements described herein for selective shrinkage oftissues. As can be understood with reference to FIG. 1, establishing thedesired temperature differential can be aided using one or moretemperature sensors coupled to the system processor. Such temperaturesensors might sense the temperature of the adjacent tissue at theprobe/tissue interface or within the adjacent tissue, or mayalternatively sense the temperature of the target tissue using surfaceor needle mounted thermal couples, thermistors, diodes, or the like.Such temperature sensors will typically transmit signals of the measuredtarget tissue temperatures to the processor, which will use thesesignals to determine whether the desired temperature differential hasbeen provided. The processor may optionally vary electrical pre-heatcurrent, a pre-heat duty cycle, a total pre-heat time, a totalpre-cooling time, a probe surface temperature, a pre-cooling duty cycle,or the like.

Probe body 84B will have a total length (and an electrode length) ofabout 3″, and will have a width of about 5″. The probe body will againideally comprise aluminum or some other body thermally conductivematerial. Some form of electrical insulation will often be providedbetween electrodes 86B, 91 and an electrically conductive probe body, asdescribed above. The electrodes may comprise stainless steel, aluminum,or a wide variety of alternative conductive materials.

Probe 84B may also be used in an alternative mode to selectivelycontract the target tissues. Pre-heat electrodes 91 have larger tissueengaging surfaces than the heating electrodes 86B, and will distributethe current over a larger tissue volume. To selectively heat tissuesabove and/or between the heating electrodes, current may be drivenbetween the large right electrode 91 and the small left heatingelectrode 84B, and then between the large left electrode and the smallright heating electrode. These overlapping currents may be driven incycles, and should help avoid over-heating and unnecessary injury to theadjacent and target tissues. A transvaginal probe 84B′ including preheatelectrodes 91 and an alternating, interleaved electrode controlarrangement is illustrated in FIG. 12Di. Preheat electrodes EA and EDprovide an initial preheat zone PH, as schematically shown in FIG.12Dii. Current is then alternated between interleaved electrode pairsEA, EC and EB, ED (as shown) to selectively heat overlapping targetzones 32A, 32B. The desired predetermined treatment temperature isachieved in a target tissue region 32C which is separated form theelectrode surfaces. A computer processor will generally control thisheating process, as generally described above.

FIGS. 12F and G illustrate a still further alternative bi-polar probestructure 84C which will produce a heating pattern that is appropriatefor tumors and other relatively thick localized target tissues 32′. Onceagain, target tissues 32′ are separated from a tissue surface by anadjacent tissue AT. Probe 84C includes concentric bi-polar electrodes86C, shown here with one of the electrodes having a circular shape andthe other having an annular shape. As described above, the adjacenttissue will often be pre-cooled through the electrodes and/or the probesurface adjacent (and often between) the electrodes.

FIGS. 12H-L illustrate a cooled bi-polar transvaginal probe withtemperature sensing capabilities, and a method for its use toselectively heat and contract in a pelvic fascia. Probe 84D include twoneedle mounted temperature sensors 95 extending from between electrodes86D. The needle mounted temperature sensors are protected by aretractable guard 97 which is withdrawn proximately after probe 84D isinserted to the treatment location. The temperature sensors are thenadvanced into the tissue by moving the probe laterally as shown in FIG.12K.

Probe 84D includes a cooling channel system 89 that cools the electrodesand the probe surface there between. The bladder wall B will preferablybe cooled by circulating a chilled fluid within the bladder (asdescribed above in FIG. 6), and pre-cooling of vaginal wall VW willoften be computer controlled using feedback from the temperaturesensors. Optionally, computer control based on this feedback might also(or instead) be provided to control pre-heating where pre-heatingcapabilities are included in the probe. Temperature sensors 95 might beused to measures the temperature at the probe/interface, within thevaginal wall, within the endopelvic fascia, or the like. Regardless,pre-chilling of probe 84D and within bladder B will often be timed andcontrolled so as to provide a temperature profile similar to thatillustrated in FIG. 3B upon the initiation of the heating currentbetween electrodes 86D.

Theoretically, if heating were initiated while the bladder wall,endopelvic fascia, and vaginal wall were at a uniform temperature, thecurrent density produced by electrodes 86D would result in considerablecollateral damage when heating the endopelvic fascia to the desiredcontraction temperature range. This uniform temperature current densityis schematically illustrated by dashed lines 99. However, as the bladderwall and the vaginal wall have been cooled to enhance their impedance,the electrical current will tend to move the current into to the warmendopelvic fascia EF, thereby enhancing localized heating of this targetstructure. This tailored current density is schematically illustrated bysolid lines 101 in FIG. 12L. This tailored current density effects thedesired contraction of the target endopelvic fascia while minimizingdamage to both adjacent tissues.

Referring now to FIG. 13, microwave probe 94 includes microwave antennas96 which direct microwave heating energy 98 through the vaginal wall VWand onto endopelvic fascia EF. Microwave probe 94 will again typicallyinclude a cooled probe surface to minimize damage to vaginal wall VW.The microwave may optionally be produced by a phased array microwaveantenna to decrease heating next to the cold probe relative to theheating of endopelvic fascia EF, or a more conventional microwaveantenna may be used.

Microwave power having a frequency of about 2250 MHz is most often usedfor heating. However, the use of extremely high frequency microwaveswould permit constructive interference at the intersection of microwaveenergy streams by control of the microwave frequency, phase, andelectrode spacing. Such constructive interference of microwaves may beused to enhance the heating of the target tissue relative to the heatproduced in the intermediate tissue between microwave probe 94 andendopelvic fascia EF (in this example). Injection of an electricallyinsulating fluid, such as Dextran™, may be used to absorb microwaveenergy and protect tissues beyond the target zone. In some embodiments,injection of a liquid contrast medium might be used to enhancevisualization of the treatment region, increasing the visibility andclarity of the vagina V, bladder B, the other adjacent organs, and thespaces therebetween. Such a contrast medium will typically be highlyvisible under ultrasonic or fluoroscopic imaging modalities.

An alternative form of energy which may be used in a probe schematicallysimilar to that illustrated in FIG. 13 is ultrasonic heating. A cooledultrasonic probe could be used to provide heating of the endopelvicfascia adjacent the vagina, preferably while protecting the adjacenttissues using a material which reflects ultrasound. Suitable protectionmaterials include CO₂ or a liquid/foam emulsion material. High intensityultrasound is able to heat tissues at a distance from the probe, and maybe focused to apply the most intense heating at a particular treatmentsite. Concentration of ultrasound energy deep in the body may avoidheating of tissues at the entry site of the focused ultrasound beam,although gas pockets and bony structures may absorb and/or reflect thefocused ultrasound energy, so that tissues may be damaged by bothlocalized heating and cavitation. Once again, the surface of anultrasound probe will typically be cooled to protect the tissues whichare directly engaged by the probe.

The absorption of ultrasound energy is generally proportional to itsfrequency. A frequency on the order of about 10 MHz would be appropriatefor penetration a distance on the order of about 1.0 cm into tissue. Thefocal accuracy is dependent on the wavelength, and at about 10 MHz thewavelength is about 0.15 mm. As a result, a very sharp focus ispossible. Although the absorption coefficient will vary with the tissuetype, this variation is relatively small. Hence, it is expected that thefocusing of an ultrasound beam will have a greater influence on powerdissipation in the intermediate tissue than will the variation inabsorption coefficient due to differing tissue types.

As illustrated schematically in FIG. 13A, a focused ultrasound probe 300having an elongate probe housing 302 is well adapted to accommodateaxial translation 304 and rotation 306 of an ultrasound transducer 308.To treat arbitrary structures by selectively varying the focal depth oftransducer 308, the transducer can optionally be in the form of anannular array.

It may be possible to make use of a fixed focal length transducer. Sucha fixed transducer will preferably be adapted to focus at a depthappropriate for the desired therapy. In some embodiments, it may bepossible to translate such a fixed focal length transducer relative tothe fascial layer to treat tissues at differing depths. Alternatively,by making use of the multiple elements of a phased array, the transducercan be dynamically focused on the treatment region by phasing theexcitation drive current to the array elements. Advantageously,treatment may be performed using a continuous wave excitation,significantly facilitating phasing of the drive currents to theindividual array elements.

As illustrated in FIGS. 13B and C, annular arrays are particularly welladapted for focusing ultrasound energy at a focus point 310. By varyingthe electrical current supplied to the individual annular shapedelements 312 a, 312 b, . . . of annular array 308 using phase control314, the focal depth of the annular array can be increased to 310′ ordecreased to 310″.

While the ultrasound emitting structure is herein generally referred toas a transducer, ultrasound transmitters which do not also senseultrasound energy might be used. Nonetheless, it may be advantageous toboth image and heat the tissue using a single transducer structure. Thetransducer may be excited with an impulse, or with a continuous signalwhere a longer duty cycle is desired. By alternating imaging andheating, the changes in the thickness or ultrasonic appearance of thetissue may be monitored to determine when the tissue has completed itstreatment.

The ability to measure the thickness of fascia and other collagenatedtissues using ultrasound energy is particularly advantageous for judgingthe completeness and/or efficacy of the thermal shrinking treatment.Hence, heating may be controlled and terminated based on ultrasoundfeedback regarding the thickness and/or change in thickness of fascia orother collagenated tissues. The generation of harmonics or subharmonicsof the fundamental carrier frequency is an indication of the productionof cavitation in the tissue, and may be used as a feedback mechanism foradjusting ultrasound power or scanning speed. Ultrasound sensed targettissue thickness feedback and control may be incorporated into probeswhich heat the target tissue using ultrasound, RF energy, microwave, orany other energy transmitting mechanism, within the scope of the presentinvention.

To make use of ultrasound's thickness sensing capabilities, an initialtarget tissue thickness may be measured and stored. During the course oftreatment, the thickness of the fascial layer (or other target tissue)can be remeasured, and the revised tissue depth may be compared to theinitial tissue depth. Changes in a fascial layer tissue depth duringtreatment may then be used as a guide to the progress and completion ofthe tissue shrinkage operation. Depth determination may be made using anexternal imager, or might be provided by an imaging A-scan from thetreatment transducer.

In some embodiments, computer feedback may be used to guide the user inthe application of ultrasound energy using ultrasound probe 300. Forexample, a computer controller may display the location of fixedreference points (such as bony structures) together with arepresentation of the physical location of the probe. Such a displaywould help illustrate the location relative to the bony structures,which may help the user dynamically guide the probe to the desiredtreatment area. In some embodiments, such a relative location image maybe provided using an external ultrasonic imager. In such embodiments,the bony structures, the treatment probe, any temperature sensingneedles, and the fascia or other target tissues could all be visiblewithin a single image. This would greatly facilitate guiding of theprobe, and may be used to selectively activate the probe so as to treatthe target tissues, either manually by the user or automatically undercomputer control.

The structure of ultrasound transducer 300 is illustrated in more detailin FIGS. 13D-G. As illustrated in FIG. 13D, coolant flow 316 willpreferably be provided through a cooling lumen 318, with the coolinglumen distributing a cooling fluid adjacent annular transducer 308. Inaddition to the chilling of tissues provided by cooling flow 316 (whichcan protect intermediate tissues outside the treatment zone), it ishighly beneficial to cool the transducer itself, as transducerstypically have an efficiency of about 60% or less. For a delivered powerof about 100 W, the input power would typically be about 167 W. As aresult, 67 W of heat should be removed from the housing adjacent thetransducer so as to prevent the surface of the transducer housing fromrising above about 45° C. As described above, it will often be desirableto chill the intermediate tissue engaged by the probes of the presentinvention to temperatures significantly lower than this. It should atleast be possible to maintain the housing below a maximum safe tissuetemperature by using an adequate flow a cooling liquid such as water,and still further cooling may be possible.

It will also be desirable to provide liquid surrounding the probe toacoustically couple the housing of the ultrasonic probe to theintermediate tissue. For example, providing a physiologically benignliquid, such as isotonic saline or Dextran™, between an ultrasonicvaginal probe and the vaginal wall will facilitate the transmission ofultrasonic power from transducer 308, through the cooling fluid andhousing of the transducer, and into the vaginal wall. In someembodiments, the liquid between the probe and the intermediate tissuemay also contain a bioactive and/or therapeutic agent, such as ananti-biotic drug to further lessen the chances of infection after theprocedure.

In the exemplary embodiment illustrated in FIGS. 13D-G, the housing ofthe probe is defined by a thick lower wall 320 and a thin upper wall322. The use of a thinner upper wall, which will generally be disposedbetween transducer 308 and the target tissue, will enhance theefficiency of acoustic coupling between the transducer and the targettissue.

An alternative ultrasound probe 330 having a linear array transducer 332is illustrated in FIGS. 13H-M. This embodiment includes many of thefeatures and advantages described above with reference to ultrasoundtransducer 300, but linear array transducer 332 includes a plurality oflinear array elements 312 a, 312 b, . . . .

In general, ultrasonic probes having a fixed, radially symmetricaltransducer can be focused to a point having a size on the order of 1wavelength. Ultrasonic probes having transducers with cylindricallysymmetrical designs will generally focus to a line with a theoreticalthickness on the order of 1 wavelength, and with a length similar to thelength of the cylindrical transducer.

In the case of a fixed radially symmetrical transducer, the probe willpreferably have an internal structure which permits the transducer torotate about the axis of probe, and also to translate along this axis.In the case of a fixed cylindrically symmetrical transducer, theinternal structure of the probe will preferably allow the transducer torotate about the axis of the probe, and may also be used to dither therotational position of the transducer about a nominal orientation. Itmay also be preferable to include at least some axial translation orscanning capabilities for fixed cylindrically symmetrical transducers.

If the transducer has a fixed focal length, it is generally advantageousto provide the transducer assembly with the ability to translateradially with respect to the axis of the probe, so that the fixed focusof the beam can be positioned at the correct depth within the tissue tobe treated. The complexity of this radial translation capability isobviated by providing linear array transducer structures having dynamicdepth focusing capabilities.

As illustrated in FIG. 13I, linear array transducer 332 will alsogenerally focus the ultrasound energy on a line 336. Advantageously, thefocal distance between the transducer and line 336 can be varied usingphase control 314. In other words, changing the phase of the individuallinear transducer elements allows the radial position of the focal lineto be varied, from line 336′ to line 336″ as illustrated in FIG. 13H.Where linear elements 334 are oriented parallel to the axis of theprobe, such a linear array is particularly well suited for treatingtissue layers that are roughly parallel to the probe.

In general, a controller will coordinate the transducer drive currentwith the location, angle, and focusing depth of the transducer, so thatthe transducer is driven only while positioned such that the focus ofthe ultrasonic beam is within the target tissue. The controller and theassociated positioning mechanism will generally keep the array orientedtoward and focused on the target tissue throughout much or all of thescan so that the transducer can be providing heat energy most of thetime.

Should it be desirable to combine a commercial ultrasonic imagingvaginal probe with an ultrasonic power treatment device, it willgenerally be preferable to position the two transducers adjacent to eachother on a single internal transducer scanning assembly. This canfacilitate rotating and translating the imaging and therapeuticultrasonic transducers together, so that the structure to be treated isalternately viewed and heated. Ideally, these alternate viewing/therapycycles will be coordinated so that one or the other is being performedsubstantially continually.

In some embodiments, it may be beneficial to update the target locationof the fascia or other target tissue throughout the procedure. This willallow the therapy to remain focused upon a support tissue such as theendopelvic fascia, even when the support tissue is changing in shapeand/or position, which will often occur during a successful treatment.

A cross-section of a grasping bipolar probe 100 is illustrated in FIG.14. Grasping probe 100 grips and folds an anterior portion of thevaginal wall, together with the endopelvic fascia EF, as shown. Itshould be understood that the targeted fascia may be separated from theprobe by muscle, vasculature, and the like, as well as by vaginal wallVW. Endopelvic fascia EF is typically about 1 mm thick, while thegrasped, folded vaginal wall will typically be between about 10 mm to 14mm thick. The folded endopelvic fascia EF may thus be heated andcontracted between cooled bipolar electrodes 102, as described above.Depending on the length of the fold, cooled bipolar electrodes 102 mayoptionally be formed as wide elongate plates. Grasping may beaccomplished mechanically or by applying a vacuum to draw the vaginalwall into a cavity 104 of grasping probe 100. By drawing the endopelvicfascia into close proximity of both electrodes, a finer focusing of theheating may be accomplished, thereby minimizing the damage to adjacenttissues. Additionally, grasping probe 100 may draw the tissue inward torelieve any tension in the fascia, thereby enhancing the shrinkage. Asdescribed above regarding FIG. 12, CO₂ or some other insulating mediummay be used for additional protection of adjacent tissues and organs.

A kit 110 includes vaginal probe 42 and instructions 112 for use of theprobe to shrink tissues, the probe and instructions disposed inpackaging 114. The instructions may set forth the method steps for usingprobe 42 described hereinabove for selectively shrinking pelvic supporttissues as a therapy for urinary incontinence, or may alternativelyrecite any of the other described methods. Additional elements forsystem 10 (see FIG. 1) may also be included in kit 110, or may bepackaged separately.

Instructions 112 will often comprise printed material, and may be foundin whole or in part on packaging 114. Alternatively, instructions 112may be in the form of a recording disk or other computer-readable data,a video tape, a sound recording, or the like.

Referring now to FIGS. 16A-C, a transurethral probe 150 may be used toshrink endopelvic fascia between bladder B and vagina V using aconductive fluid electrotherapy system 152. Transurethral probe 150includes a shaft 154 having an electrode 156 near its distal end. Atoroidal balloon 158 seals around the shaft to prevent fluidcommunication between bladder B and urethra UR. Fluid in-flow andout-flow ports 160, 162 allow both gas and liquid to be introduced intothe bladder in controlled amounts, and also allow a conductive fluid 164(typically an electrolytic liquid, and ideally comprising a chilledsaline solution), to be circulated within the bladder.

An insulating fluid 166 having a density much less than that ofconductive fluid 164 occupies a portion of bladder B away from thetissues targeted for treatment. As electrode 156 is within conductivefluid 164, the conductive fluid can transmit RF current between theelectrode and a cooled plate electrode of a vaginal probe 168. Theconductive properties of conductive fluid 164 may be optimized for bothconduction of electricity (for example, by controlling the salinity of asaline solution), and for directly transferring heat from the bladderwall.

A cross-section of shaft 154 is illustrated in FIG. 16B. As describedabove, an in-flow lumen 176 allows the introduction of both insulatingfluid 166 and conductive fluid 164 through in-flow port 160. An out-flowlumen 178 is similarly in fluid communication with out-flow port 162 toallow recirculation of chilled saline or the like, and also tofacilitate removal of the fluids from the bladder after the procedure.RF energy is provided to electrode 156 through wire 180, and a ballooninflation lumen 182 allows transurethral probe to be inserted andremoved with a minimum amount of trauma, while still ensuring anadequate seal of the body cavity. Electrode 156 may extend within thebladder (as shown in FIG. 16C) to increase the electrode surface areaexposed to conductive fluid 164. This may help minimize localizedheating at the electrode surface. Inadvertent contact between thebladder wall and electrode surface may be avoided by surrounding theelectrode surface with a protective mesh.

In the embodiment of FIG. 16C, vaginal probe 168 includes a flexibleshaft 170 and a distal balloon 172. Engagement between an electrode 174and the vaginal wall is enhanced by inflating the balloon within vaginaV, while cooling of the electrode surface may be provided by circulatingfluid within the balloon. The electrode may have a flat electrodesurface with rounded edges, as described above.

In use, the patient will be positioned on her back (so that the portionof the endopelvic fascia targeted for shrinkage is disposed verticallybelow the bladder), and transurethral probe 150 will be introducedthrough urethra UR to bladder B. Toroidal balloon 158 can then beinflated to seal around the transurethral probe, and the bladder can bepartially filled with insulating fluid 166, typically using air or a gassuch as carbon dioxide. The bladder is also partially filled withconductive fluid 164, typically in the form of a chilled electrolyticliquid such as saline. The bladder wall may be further cooled by cyclingthe chilled saline before, during, and/or after heating, as generallydescribed above regarding FIGS. 2 and 3.

The volumes of the fluids introduced into the bladder will be selectedto provide therapy over the target tissue, and to minimize heatingbeyond the target tissue. Preferably, the volumes and positions ofconductive fluid 164 and insulating fluid 166 are maintained throughoutthe procedure. As electrode 156 is in contact with conductive fluid 164,the conductive fluid effectively forms a large area electrode at thefloor of the bladder, while the gas provides an electrical (and thermal)insulator at the top of the bladder. Maintaining the relative volumes offluid limits heating to below a gas/liquid interface 184.

Transvaginal probe 168 is introduced and positioned to the extreme rightor left side of the pelvis so that electrode 174 is oriented towards theinterface between conductive fluid 164 and the lower right side or lowerleft side of the bladder wall. Probe balloon 172 can then be inflated,and the bladder wall and vaginal mucosa can be pre-chilled bycirculating fluid through the probes. Once these tissues are properlypre-cooled, heating can proceed as described above, with the conductivefluid/bladder wall interface acting as one plate electrode, andelectrode 174 on balloon 172 of vaginal probe 168 acting as the other.As was also described above, the electrode of vaginal probe 168 may besegmented to target heating on the target tissue, and to minimize anyunwanted concentrations of heating caused by the variations in totaltissue depth, non-parallel tissue surface effects, and the like.

Referring now to FIGS. 17A and B, a similar method for shrinkingendopelvic fascia to that described above regarding FIGS. 16A-C may bepracticed using a transurethral probe having an inflatable spoon shapedballoon 200. Spoon shaped balloon 200 supports a deployable electrode202, and can be used to orient the deployable electrode toward vaginalprobe 168. This may enhance control over the heating current flux, andspoon shaped balloon 200 (as well as balloon 172 of vaginal probe 168)may be insulated away from the electrode surface to further limit injuryto the bladder wall. Deployable electrode 202 may also be segmented asdescribed above, and will provide a small cross-sectional profile priorto inflation so as to minimize trauma during insertion.

A two probe device 250 is illustrated in FIG. 18A. Two probe device 250will be used in a method similar to that described above with referenceto FIG. 6, but here includes both a transvaginal probe 252 and atransrectal probe 254. Each of these probes includes a proximal end 256and a distal end 258. The distal ends are sized and shaped for insertioninto their respective body cavities. Proximal ends 256 are mechanicallycoupled by a clamp structure 260. Rotating a handle 262 of clampstructure 260 changes a separation distance 264 between electrodes 266,268 via threads 270. Hence, clamping structure 260 helps maintain theparallel alignment between the electrodes, and also helps to compressthe tissue between the electrode surfaces.

It should be understood that a wide variety of mechanical actuatorsmight be used in place of the threaded mechanism illustrated in FIG.18A. Parallel bar linkages, ratcheted sliding joints, rack-and-pinionmechanisms, and recirculating ball linear actuators are just a fewexamples of alternative mechanisms which might be used. In someembodiments, the probes may be inserted independently, and then coupledtogether using a releasable clamping structure.

A wide variety of actuators may also be used in place of handle 262,including electromechanical actuator, pneumatic actuators, and the like.In some embodiments, the clamping structure may provide feedback onseparation distance 264. More complex arrangements are also possible, inwhich the structure coupling the probes includes joints or flexiblestructures with position indicating capabilities. Such structures mayprovide feedback for driving segmented electrodes so as to selectivelytailor the heat energy, often to evenly heat the desired target tissuesby compensating for any misalignment between the electrodes, angularitybetween the electrode surfaces, and the like, was generally describedwith reference to FIGS. 2-2D.

Probes 252, 254 will also include many of the structures describedabove, including a cooling system having in-flow ports 272 and outflowports 274 to cool electrodes 266, 268 through cooling system lumens 276.A needle mounted temperature sensor 278 may be advanced into the clampedtissue from adjacent one electrode to provide feedback on theheating/cooling of tissues. Such temperature information may betransmitted to a controller using temperature sensor wires 280. RFenergy will be transmitted down the probes via electrode conductors 282.

In use, two probe clamp 250 will be positioned with one of the probesextending into the rectum, and the other probe extending into thevagina. Clamping structure 260 will be actuated using handle 262 todecrease the separation distance 264, and to clamp the target tissuebetween electrodes 266, 268. Needle mounted temperature sensor 278 willextend into the clamped tissue, ideally extending into the targettissue.

Clamping of the tissue will help ensure firm engagement between theelectrodes and the tissue surfaces, and will also promote even heatingby minimizing the ratio between separation distance 264 and electrodewidths 284. The clamp structure is sufficiently stiff to maintain theelectrode structures substantially in alignment, and also to maintainthe electrode surfaces roughly parallel to each other, so as to becapable of providing sufficiently uniform current flux to shrink thetarget tissue. Where the electrodes are segmented (as described above),the clamping structure may accommodate significant angularity betweenthe electrode surfaces, as well as some axial and lateral misalignment,while still effectively heating and shrinking the target tissue withminimal collateral damage. In the exemplary embodiment, electrodes 266,268 are positioned at closer proximity to each other than probes 252,254 proximal of the electrodes. This avoids injury to tissues proximalof the electrodes, particularly to the rectal and vaginal sphincters,when the clamping mechanism brings the probes together.

While two probe device 250 is illustrated having two separate probeswhich are both adapted for insertion into the body, it should beunderstood that a similar clamping structure may make use of a singleinsertable probe carrying an electrode, and a second electrode supportstructure adapted for use on the exposed skin. In some embodiments, itmay be preferable to limit heating of the skin engaged by using anexternal electrode having a surface which is significantly larger thanthat of the internal electrode. This may reduce and/or eliminate theneed for active cooling of the external electrode, and will concentrateheating closer to the smaller, cooled internal electrode surface.

The transvaginal/transrectal two probe device of FIG. 18A isparticularly suitable for use as a therapy for rectocele. Similar probestructures will find use in a wide variety of applications, includingmany of those described above, as well as those described in U.S. patentapplication Ser. No. 08/910,370, filed Aug. 13, 1997, previouslyincorporated by reference. For example, the vaginal wall (including theendopelvic fascia) may be drawn downward between a pair of electrodesfor selectively shrinking of the pelvic support tissues as a therapy forincontinence. Similar therapies may be possible for the colon.

In some embodiments, a vaginal probe similar to those described abovemay be mechanically coupled to a rectal probe for stabilizing theposition of the vaginal probe. The rectal probe may optionally include aballoon to apply pressure to the vaginal probe, thus squeezing the twoprobes together. This may help to stabilize the location and directionof the vaginal probe so that it can provide heating to the deep tissuesabove and to the sides of the vagina. Such a stabilized vaginal probemay be used with many of the energy transmitting structures describedabove, including focused ultrasound transducers.

Still further alternative structures may be used to enhance positionalaccuracy of the probes of the present invention within body cavitiessuch as the vagina. For example, an O ring may be sized to fittinglyengage the surrounding vaginal wall so as to provide mechanicalstabilization. Such an O ring may be variable in size, or may beavailable in a variety of selectable sizes. In some embodiments,mechanical stabilization may be provided using an inflatable cuffdisposed around the shaft of the probe. Such a cuff could be inflatedafter the probe is positioned to engage the surrounding tissue toprovide mechanical stabilization.

A fixed reference marker might also be used for positioning and/orposition verification. A reference marker might be attached to the pubicsymphysis, or to some other convenient bony structure. Such a marker maybe used to position the probe, to measure the relative position of oneor more probes, or to correct the calculated position of the proberelative to the target tissue, relative to a second electrode, or thelike.

An adhesive surface or sticky pad on the probe may allow the probe toadhere to the inner vaginal surface. It may be preferable to adhesivelyaffix only a portion of the probe, particularly where an alternateportion can translate and/or rotate with respect to the fixed portion.This might permit the treatment region to be conveniently controlledwith reference to the fixed portion. A similar (and more readilyreleasable) result may be provided by using a vacuum attachmentmechanism.

Still further mechanical mechanisms are possible. In some embodiments,it may be desirable to provide an external fixture to hold an energyapplying probe with reference to bony structures of the body. Such anexternal fixture may provide a mechanism for translating the treatmentprobe along a trajectory which optimally treat the targeted fascia.

Two-probe devices may also be used in a minimally invasive, or even in astandard open procedure. For example, a pair of substantially parallelneedles may be inserted on either side of a target tissue. The needleswill preferably be insulated along a proximal portion and electricallyand thermally conductive adjacent a distal region. RF energy may bedriven between the conductive distal regions of the needles to heat thetissue therebetween. Such needle electrodes will preferably includeradially expandable structures such as balloons supporting theconductive distal regions. This allows a radius of curvature of theconductive distal regions to be increased by inflating the balloons oncethe needles are in position. By increasing the radius of curvaturesufficiently relative to the separation between electrodes, the spatialuniformity of the heating can be enhanced. Chilled balloon inflationfluid can limit heating of the tissue adjacent the balloon.

The present invention further encompasses methods for teaching theabove-described methods by demonstrating the methods of the presentinvention on patients, animals, physical or computer models, and thelike.

While the exemplary embodiments have been described in some detail, byway of example and for clarity of understanding, a variety ofmodifications, adaptations, and changes will be obvious to those whoskill in the art. For example, substantially coaxial cylindricalelectrode surfaces may clamp tubular tissues (such as the cervix)between cooled parallel surfaces for treatment and/or shrinkage.Alternatively, a conductive liquid and an insulating liquid havingdiffering densities may be used to selectively couple an electrode to aportion of a tissue surface within a body cavity, or substantiallycoaxial cylindrical electrode surfaces might clamp tubular tissues (suchas the cervix) between cooled parallel surfaces for treatment and/orshrinkage. Therefore, the scope of the present invention is limitedsolely by the appended claims.

1. A method for teaching, the method comprising: demonstrating coolingof a surface with a probe; and demonstrating directing of energy fromthe probe through the surface and into an underlying structure to effectshrinkage of the structure. 2-32. (canceled)
 33. A method forselectively heating a predetermined target tissue, the target tissueadjacent another tissue, the method comprising: generating a temperaturedifferential between the adjacent tissue and the target tissue; andheating the target tissue by conducting a heating electrical currentinto the target tissue after generating the temperature differential sothat the temperature differential urges the heating current from theadjacent tissue into the target tissue; wherein the heating step ablatesthe target tissue, the target tissue comprising a tumor.
 34. A systemfor selectively heating a predetermined target tissue, the target tissueadjacent another tissue, the system comprising: a probe having a surfaceoriented for engaging a tissue surface; a member selected from the groupconsisting of a pre-cooler and a pre-heater coupled to the probe surfaceso as to produce a temperature differential between the target tissueand the adjacent tissue; and at least one tissue heating electrodecoupleable to the target tissue to conduct an electrical current intothe tissues, the at least one heating electrode defining a nominalcurrent distribution when the current is conducted into the tissues andthe tissues are at a uniform body temperature, the at least one heatingelectrode producing a tailored current distribution when the current isconducted into the tissues and the tissues exhibit the temperaturedifferential, the tailored current distribution resulting in lesscollateral damage to the adjacent tissues than the nominal currentdistribution when the target tissue is heated by the current to atreatment temperature.
 35. The system of claim 34, further comprising aprocessor coupled to the member to align the temperature differentialbetween the target tissue and the adjacent tissue.
 36. The system ofclaim 35, wherein the processor initiates heating once a predeterminedtemperature differential is achieved.
 37. The system of claim 36,wherein the processor is coupled to the pre-heater and to thepre-cooler, and wherein the pre-heater comprises an energy transmittingelement that is separate from the at least one electrode.
 38. The systemof claim 35, further comprising a first temperature sensor coupled tothe processor, the first temperature sensor transmitting an adjacenttissue temperature signal to the processor, wherein the processordetermines the temperature differential at least in part from theadjacent tissue temperature signal.
 39. The system of claim 38, furthercomprising a second temperature sensor coupled to the processor, thesecond temperature sensor transmitting a target tissue temperaturesignal to the processor, wherein the processor determines thetemperature differential at least in part from the target tissuetemperature signal.
 40. The system of claim 35, wherein the membercomprises a pre-heat electrode, and wherein the processor can vary atleast one element of the group consisting of electrical pre-heat currentfrom the pre-heat electrode, a pre-heat current duty cycle, and a totalpre-heat time.
 41. The system of claim 35, wherein the member comprisesa pre-cooler, and wherein the processor can vary at least one elementselected from the group consisting of a total pre-cooling time, a probesurface temperature, and a pre-cooling duty cycle.
 42. The system ofclaim 34, wherein the at least one heating electrode is mounted to theprobe.
 43. The system of claim 42, wherein the pre-cooler can cool theat least one heating electrode so that the at least one heatingelectrode pre-cools the adjacent tissue when the adjacent tissue isdisposed between the at least one heating electrode and the targettissue.
 44. The system of claim 43, wherein the at least one heatingelectrode comprises a pair of bipolar heating electrodes along the probesurface, wherein the pre-cooler comprises cooled electrode surfaces ofthe heating electrodes and a cooled heat transfer surface disposedtherebetween.
 45. The system of claim 44, wherein the heating electrodesdefine a width and are separated by a separation distance in a rangefrom about ⅓ to about 5 times the width.
 46. The system of claim 44,further comprising a pair of bipolar pre-heat electrodes disposed alongthe probe surface with the heating electrodes disposed therebetween. 47.The system of claim 34, further comprising a processor coupled to the atleast one heating electrode and to the member, the processor controllingthe temperature differential and the current so as to shrink the targettissue while avoiding collateral damage to the adjacent tissue, thetarget tissue comprising collagen.
 48. The system of claim 34, whereinthe probe has a size and shape suitable for transvaginal insertion, theat least one heating electrode, the temperature differential member, andprocessor being capable of selectively shrinking an endopelvic supporttissue so as to inhibit incontinence.